Esbriet is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal.

Esbriet is not a cure for IPF, but this medicine may slow the progress of this disease.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Esbriet if you are allergic to pirfenidone.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• if you smoke.

It is not known whether Esbriet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pirfenidone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Take Esbriet exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Esbriet.

Take this medicine with food at the same time each day.

Esbriet is usually taken 3 times per day. Your dose needs will change over the first 15 days of your treatment.

• For the first week, you will take only 1 capsule or tablet at a time.

• During the second week, you will take 2 capsules or tablets at a time.

• From the third week on, you will take 3 capsules or tablets at a time.

If you use the 801-milligram tablet from the third week on you will take only 1 tablet at a time, 3 times per day.

You should not take more than 3 doses per day.

You must follow this first-2-week "dose escalation" schedule when you start taking Esbriet, or if you start taking the medicine again after not taking it for 14 days or longer. Follow your doctor's dosing instructions very carefully.

If you do stop taking Esbriet for any reason, talk with your doctor before restarting the medicine.

You may need frequent medical tests to be sure pirfenidone is not causing harmful effects on your liver. Your next few doses may be delayed or reduced based on the results of these tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

Initial dose:
-Days 1 to 7: 267 mg (one capsule) orally three times a day
-Days 8 to 14: 534 mg (two capsules) orally three times a day
Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day

Comments:
-Take with food to reduce nausea and dizziness.
-Doses should be taken at the same time each day.

Use: Idiopathic pulmonary fibrosis (IPF)

You should not use Esbriet if you are allergic to pirfenidone.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• if you smoke.

It is not known whether Esbriet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pirfenidone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid exposure to sunlight or tanning beds. Esbriet can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tell your doctor if you are also using antibiotic medicine, which can also make you more sensitive to sunlight.

Avoid or limit grapefruit products while taking Esbriet as it can increase drug levels in your blood.

Avoid smoking while taking this medicine. Smoking could make Esbriet less effective.

Get emergency medical help if you have signs of an allergic reaction to Esbriet: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe ongoing stomach pain, vomiting, diarrhea;

• burning or pain in your esophagus or throat; or

• liver problems--stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Esbriet side effects may include:

• nausea, vomiting, loss of appetite;

• stomach pain, heartburn, upset stomach;

• diarrhea;

• headache, dizziness, tired feeling;

• weight loss;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• joint pain;

• rash, skin sensitivity to sunlight; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with pirfenidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.